The Effects of Neurorehabilitation Approaches Involving Different Upper Extremity Reactive Trainings in Stroke Patients

NCT ID: NCT06086314

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2025-11-15

Brief Summary

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The goal of this clinical trial is to investigate the effectiveness of upper extremity training, which is expected for 5 seconds on the target during reaching forward, and to compare the effectiveness of neurorehabilitation interventions including reactive upper extremity trainings to be applied with different speeds and methods on body control, balance, gait, fall risk and spasticity in the individuals with stroke. The main questions it aims to answer is:

• Is there a difference in the effects of neurorehabilitation interventions that include reactive upper extremity trainings applied at different speeds and methods on trunk control, balance, gait, fall risk and upper extremity spasticity?

All participants will participate in the Bobath Approach-based neurorehabilitation program. This program will include scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity.

* In addition to the neurorehabilitation program, the 1st and 2nd groups will be given a reaching exercise with LED light reactive training material (Fitpodz Light Trainer®). The LED light sensors, whose duration is set, will light up in green and red colors at random intervals.

* Patients in the 1st group will be asked to reach forward and touch the sensor when the red light sensor is on, and pull back as soon as the sensor goes out.
* The patients in the 2nd group will be asked to reach forward and touch the sensor when the green light sensor is lit, and to hold their hand on the sensor for 5 seconds and then withdraw it. With this method, it is aimed to create co-contraction in patients in Group 2.
* In addition to the neurorehabilitation program, patients in the 3rd group (control group) will have functional stretches to the anterior, right and left while standing.

Researchers will compare three groups to see if there a difference in the effects of neurorehabilitation interventions that include reactive upper extremity trainings applied at different speeds and methods.

Detailed Description

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* In the trainings of the 1st and 2nd groups, 4 LED light sensors will be placed on the wall at shoulder level in the standing position of the patient. The distance of the patient to the wall will be determined by using the value obtained from the Functional Reach Test according to his or her arm length.
* The Bobath Approach-based neurorehabilitation training will take 30 minutes per session.
* After the Bobath Approach-based neurorehabilitation training, all groups will perform 3 sets of training, 10 repetitions per set for each extremity. An equal number of stretches will be made in total in each direction, but the directions will be determined randomly. There will be a 3-minute rest break between sets.
* All groups will receive training for a total of 7 weeks, 3 sessions per week.

Conditions

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Stroke Spastic Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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reactive exercise training

They will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive reactive exercise training with ''FitPodz Light Trainer'' device.

Group Type EXPERIMENTAL

reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program

Intervention Type DEVICE

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the red light sensor is on, and withdrawing his/her hand as soon as the sensor goes out.

reactive exercise training with co-contraction

They will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive reactive exercise training aimed at creating co-contraction with ''FitPodz Light Trainer'' device.

Group Type EXPERIMENTAL

reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.

Intervention Type DEVICE

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the green light sensor is on, and holding his/her hand on the sensor for 5 seconds and then withdrawing it.

functional reaching training

They will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive functional reaching training without device.

Group Type ACTIVE_COMPARATOR

neurorehabilitation program with functional reaching training without device.

Intervention Type OTHER

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Doing functional stretching to the anterior, right and left while standing.

Interventions

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reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the red light sensor is on, and withdrawing his/her hand as soon as the sensor goes out.

Intervention Type DEVICE

reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the green light sensor is on, and holding his/her hand on the sensor for 5 seconds and then withdrawing it.

Intervention Type DEVICE

neurorehabilitation program with functional reaching training without device.

Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Doing functional stretching to the anterior, right and left while standing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18-80
* ≥3 months after stroke
* Elbow flexor spasticity ≤2 according to MAS
* Being able to sit independently and stand with or without walking aid
* Being an individual with a Functional Ambulation Classification ≥3
* Being an individual with a Hodkinson Mental Test score ≥6

Exclusion Criteria

* Presence of another neurological disease that will affect trunk control other than stroke
* Having acute back or lower extremity pain
* Having an acute illness (eg vomiting, fever)
* Recent surgery on the upper-lower extremities or trunk
* Having a condition or activity restriction that prevents participation in the program
* Inability to sit or stand independently
* Having abnormal or unstable cardiovascular responses to exercise
* Having cognitive impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Nur Alçın

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilüfer Çetişli Korkmaz, Prof.

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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FizyoFi Physiotherapy Consultancy Center

Gölhisar, Burdur, Turkey (Türkiye)

Site Status

Gölhisar Vocational School of Health Sciences

Gölhisar, Burdur, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.

Reference Type BACKGROUND
PMID: 34635141 (View on PubMed)

Lee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.

Reference Type BACKGROUND
PMID: 33136074 (View on PubMed)

Park H, Kim S, Winstein CJ, Gordon J, Schweighofer N. Short-Duration and Intensive Training Improves Long-Term Reaching Performance in Individuals With Chronic Stroke. Neurorehabil Neural Repair. 2016 Jul;30(6):551-61. doi: 10.1177/1545968315606990. Epub 2015 Sep 24.

Reference Type BACKGROUND
PMID: 26405046 (View on PubMed)

Shin JW, Don Kim K. The effect of enhanced trunk control on balance and falls through bilateral upper extremity exercises among chronic stroke patients in a standing position. J Phys Ther Sci. 2016 Jan;28(1):194-7. doi: 10.1589/jpts.28.194. Epub 2016 Jan 30.

Reference Type BACKGROUND
PMID: 26957756 (View on PubMed)

Other Identifiers

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26.07.2023-E.396979

Identifier Type: -

Identifier Source: org_study_id

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